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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data from secondary source

Data source

Reference
Reference Type:
secondary source
Title:
Skin sensitization study of 3-chloropropyl)triethoxysilane was performed in guinea pig
Author:
OECD HPV SIDS
Year:
2010
Bibliographic source:
OECD HPV Chemical Programme, SIDS Dossier approved at SIAM 30, 20-22 April 2010

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Skin sensitization study of 3-chloropropyl)triethoxysilane was performed in guinea pig by using Guinea pig maximisation test
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 3-chloropropyl)triethoxysilane
- Molecular formula : C9H21ClO3Si
- Molecular weight :240.801g/mol
- Substance type: organic
- Physical state: liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): 3-chloropropyl)triethoxysilane
- Molecular formula : C9H21ClO3Si
- Molecular weight :240.801g/mol
- Substance type: organic
- Physical state: liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: albino SPF
Sex:
male
Details on test animals and environmental conditions:
No data available

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
propylene glycol
Concentration / amount:
5%
Route:
epicutaneous, occlusive
Vehicle:
other: Vaseline
Concentration / amount:
10%
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: Vaseline
Concentration / amount:
5%
No. of animals per dose:
Total :20
Treated group:15
Control group:5
Details on study design:
Details on study design
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:2
- Exposure period: No data available
- Test groups:15
- Control group:5
- Site: No data available

- Frequency of applications:
- Duration: No data available

- Concentrations: 1)5%
2) 10%

B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: No data available

- Exposure period: No data available

- Test groups:15
- Control group:5
- Site: No data available

- Concentrations:5 %
- Evaluation (hr after challenge): No data available


OTHER: Freund's Complete Adjuvant (FCA) used
Challenge controls:
No data available
Positive control substance(s):
no

Study design: in vivo (LLNA)

Statistics:
No data available

Results and discussion

Positive control results:
No data available

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test group
Dose level:
5%
No. with + reactions:
0
Total no. in group:
15
Clinical observations:
no indication of skin sensitization after the challenge
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: Not Sensitizing
Conclusions:
The skin sensitization study of 3-chloropropyl)triethoxysilane (5089-70-3)was performed by Guinea pig maximisation test was considered to be not skin sensitizing in guinea pig .

Executive summary:

The skin sensitization study of 3-chloropropyl)triethoxysilane (5089-70-3) was performed by Guinea pig maximisation test in15 Male albino SPF guinea pigs. An additional 5 animals served as the negative control group; a positive control group was not included in the study.

 In induction phase,1stinduction given using 5% concentration inpropylene glycol by intradermal route while in 2ndinduction done by using 10% concentration in Vaseline by topical application.Freund's Complete Adjuvant (FCA) also used in induction phase.

In challenge phase, test substance 5% concentration in Vaseline applied topically. Freund's Complete Adjuvant (FCA ) produced erythema, slight edema while 5% test substance in propylene glycol produced erythema, slight edema and abscesses and 5% test substance in PG + FCA: erythema and slight edema and abscesses. In second induction the 10% test substance in Vaseline induced neither erythema nor edema in the test animals upon topical application in the induction phase of the study. No skin sensitizing reaction observed after challenge application .Hence it is considered that 3-chloropropyl)triethoxysilane (5089-70-3) was not skin sensitizing in guinea pig by Guinea pig maximisation test.